Terazosin 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terazosin hydrochloride

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

G04CA03

INN (International Name):

Terazosin hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400

Patient Information leaflet

306/05
PXXXXXX
TERAZOSIN 2MG, 5MG AND 10MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
or nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Terazosin is and what it is used for
2. What you need to know before you take Terazosin
3. How to take Terazosin
4. Possible side effects
5. How to store Terazosin
6. Contents of the pack and other information
1. WHAT TERAZOSIN IS AND WHAT IT IS USED FOR
The name of this medicine is Terazosin 2mg Tablets, Terazosin 5mg
Tablets or Terazosin
10mg Tablets referred to as Terazosin throughout this leaflet.
Terazosin belongs to a group of medicines called ‘alpha blockers ’
which help to relax smooth
muscle and has been prescribed for you to treat one of the following:
• Improve the obstructive symptoms caused by benign prostatic
hyperplasia (BPH) and help
the flow of urine from the bladder
• Treat mild to moderate hypertension (high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERAZOSIN
DO NOT TAKE TERAZOSIN IF:
• You are allergic (hypersensitive) to Terazosin or any of the other
ingredients in this medicine
(listed in Section 6)
• You are allergic (hypersensitive) to other medicines in the
‘alpha blocker’ group.
• Do not take Terazosin if any of the above apply to you. If you are
not sure, talk to your doctor
or pharmacist before taking Terazosin .
• You have ever fallen over or fainted whilst passing water.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Terazosin if you:
• Are taking other medication for high blood

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terazosin 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
mg/tablet
Terazosin
5.0
as hydrochloride dihydrate
Excipients with known effect:
Lactose
Red iron oxide (E172)
Croscarmellose Sodium
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Red, round, bevelled edged uncoated tablets debossed with the
identifying code
“S152” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orally administered terazosin is indicated:
(i) for the symptomatic treatment of urinary obstruction caused by
benign
prostatic hyperplasia (BPH). Terazosin is a selective post synaptic
alpha-1-
adrenoreceptor antagonist. Antagonism of alpha-1-receptors on
prostatic and
urethral smooth muscle has been shown to improve urinary tract flow
and
relieve the urinary obstruction caused by BPH.
(ii) in the treatment of mild to moderate hypertension. It may be used
in
combination with thiazide diuretics and/or other antihypertensive
drugs or as
sole
therapy
where
other
agents
are
inappropriate
or
ineffective.
The
hypotensive effect is most pronounced on the diastolic pressure.
Although the
exact mechanism of the hypotensive action of terazosin is not
established, the
relaxation of peripheral blood vessels appears to be produced mainly
by
competitive antagonism of post-synaptic alpha
1
- adrenoreceptors. Terazosin
usually produces an initial gradual decrease in blood pressure
followed by a
sustained antihypertensive action.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS ONLY:
The dose of terazosin should be adjusted according to the patient's
response. The
following is a guide to administration:
INITIAL DOSE
1 mg before bedtime is the starting dose for all patients and should
not be exceeded.
Strict compliance with this recommendation should be observed to
minimise acute
first-dose hypotensive episodes. Therefore, use of an alternative
preparation will be
necessary for initiation of therapy.
SUBSEQUENT DOSE
IN THE TREATMENT